510(k) · Cleared
ClearedBilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entific Medical Systems, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Jul 23, 2001 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.
- Decided
- Jul 23, 2001
- Review
- 74 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 1 citing it directly.
- This deviceK011438 Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha)…Entific Medical Systems, Inc. · 2001
- Descendant · cites it directly · 39 of its ownK042017 Baha DivinoEntific Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 35 of its ownK081606 Baha IntensoCochlear Americas · 2008
- Descendant · 2 generations on · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · 2 generations on · 19 of its ownK082108 Obc Bone Anchored Hearing Aid SystemOticon Medical AB · 2008
- Descendant · 2 generations on · 18 of its ownK090996 Ponto ProOticon Medical AB · 2009
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K042017Baha DivinoEntific Medical Systems, Inc. · 2004 · cites it directly39descendants
- K081606Baha IntensoCochlear Americas · 2008 · 2 generations on35descendants
- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · 2 generations on33descendants
- K082108Obc Bone Anchored Hearing Aid SystemOticon Medical AB · 2008 · 2 generations on19descendants
- K090996Ponto ProOticon Medical AB · 2009 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011438 | Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System. | Entific Medical Systems, Inc. | 2001 | — |
| +1 | K042017 | Baha Divino | Entific Medical Systems, Inc. | 2004 | — |
| +2 | K081606 | Baha Intenso | Cochlear Americas | 2008 | — |
| +2 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +2 | K082108 | Obc Bone Anchored Hearing Aid System | Oticon Medical AB | 2008 | — |
| +2 | K090996 | Ponto Pro | Oticon Medical AB | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LXB device
- #1 K254296 Ossiclear (Ossiclear System)score 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042017 | Baha Divino | 2004 | 39 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042017 (Entific Medical Systems, Inc., 2004) has gone furthest, with 39 descendants of its own.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LXB
79in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXB
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXB
261in 2025
MAUDE reports naming product code LXB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 110 |
| 2009 | 2 | — | 0 | 76 |
| 2010 | 2 | — | 0 | 91 |
| 2011 | 5 | 189 | 0 | 123 |
| 2012 | 1 | — | 5 | 346 |
| 2013 | 5 | 103 | 0 | 640 |
| 2014 | 0 | — | 0 | 545 |
| 2015 | 2 | — | 0 | 824 |
| 2016 | 4 | 110 | 0 | 692 |
| 2017 | 1 | — | 0 | 379 |
| 2018 | 1 | — | 1 | 336 |
| 2019 | 1 | — | 0 | 497 |
| 2020 | 0 | — | 0 | 547 |
| 2021 | 4 | 79 | 0 | 490 |
| 2022 | 0 | — | 0 | 387 |
| 2023 | 0 | — | 0 | 348 |
| 2024 | 0 | — | 0 | 232 |
| 2025 | 2 | — | 0 | 261 |
| 2026 | 4 | 164 | 0 | — |
https://510kreport.com/device/K011438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011438: Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011438
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026